Interaction Between Fluvoxamine and Sildenafil

This study has been completed.
Information provided by:
Heidelberg University Identifier:
First received: September 9, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

Aim of the study is to assess the interaction between sildenafil and fluvoxamine and its effect on the venous response to sodium nitroprusside.

Condition Intervention Phase
Drug: sildenafil, fluvoxamine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Pharmacokinetic and Pharmacodynamic Evaluation of the Interaction Between Fluvoxamine and Sildenafil in Healthy Males

Resource links provided by NLM:

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Drug-induced changes of hand vein compliance
  • Drug-induced changes of pharmacokinetic parameters

Estimated Enrollment: 12
Study Start Date: February 2003
Estimated Study Completion Date: November 2004
Detailed Description:

In a randomised, double-blind, placebo-controlled, cross-over study in healthy men we will assess the effect of oral fluvoxamine (50mg qd on day 1-3; 100mg qd on day 4-10) on sildenafil kinetics (single oral 50mg dose on day 11). Sildenafil plasma concentrations will be determined by LC/MS. We will also assess the effect of sildenafil on venodilation induced by a constant dose-rate of the NO-donor sodium nitroprusside (SNP) during preconstriction with phenylephrine (dorsal hand vein compliance technique).


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy, male individuals, age: 18-45.
  • Able and willing to give written informed consent

Exclusion Criteria:

  • Hypotension ( 65 mmHg diastolic and  100 mmHg systolic blood pressure)
  • Bleeding disorders in medical history
  • Intake of medication impairing platelet function or influencing coagulation (for example aspirin, NSAID and others) during the preceding 4 weeks
  • Known condition causing endothelial dysfunction (e.g. diabetes, hyperlipidaemia, arterial hypertension, hyperhomocysteinaemia, smoking)
  • Anatomic deformity of the penis like angulation, penile fibromatosis (peyronie’s disease) or diseases favouring priapism (e.g. leukaemia, plasmocytoma, sickle-cell anaemia)
  • Regular medication and/or treatment with drugs within the preceding 4-6 weeks (exclusion has to be decided in each case)
  • alcohol (>30 g/d) or drug abuse
  • Acute or chronic illness
  • Blood donation within the preceding 2 months
  • Participation in clinical trial within 2 month before the study
  • Drug and/or alcohol abuse.
  Contacts and Locations
Please refer to this study by its identifier: NCT00175981

Dept. of Internal Medicine VI, University of Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Principal Investigator: Walter E Haefeli, MD Heidelberg University
  More Information

No publications provided Identifier: NCT00175981     History of Changes
Other Study ID Numbers: K058
Study First Received: September 9, 2005
Last Updated: September 9, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors processed this record on April 17, 2014